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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution

  • 00852423006073 ()
9700

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution

  • 00852423006066 ()
9715

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-20 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-20
In Commercial Distribution

  • 00852423006059 ()
9710

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-25 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-25
In Commercial Distribution

  • 00852423006042 ()
9725

  • Perineometer
  • Psychophysiological biofeedback system
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software
BioSerenity-Link is a mobile application capable of sharing phone connectivity, recording video and uploading it to the BioSerenity Cloud
BIOSERENITY MEDICAL DEVICES GROUP
5100-00021-UN
Not in Commercial Distribution

  • 03615220003785 ()


  • Camera application software
  • Medical networking interface unit
OPTION, SPACELABS SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108792 ()
R-91496-U

  • Patient monitoring system module, multifunction
OPTION, NELLCOR OXIMAX SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108785 ()
R-91496-N

  • Patient monitoring system module, multifunction
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